Vietnam: Documents attesting origins of herbal ingredients and traditional drugs

Circular No. 13/2018/TT-BYT on the quality of herbal ingredients and traditional drugs was issued by the Ministry of Health of Vietnam, effective from June 30, 2018, replacing Circular No. 05/2014/TT-BYT.

According to Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam, documents attesting origins of herbal ingredients and traditional drugs include:

1. Documents attesting the origin of imported herbal ingredients which are not in the list of herbal ingredients to be registered include:

- Certificate of origin (C/O) issued by a competent authority of the exporting country to each batch of herbal ingredients;

- Certificate of quality (C/Q) and Testing report (enclosed with Vietnamese translations thereof) issued to each batch of herbal ingredients.

2. Documents attesting the origin of herbal ingredients cultivated, harvested or naturally extracted by a domestic establishment meeting the Good Agricultural and Collection Practices (GACP) requirements include: Documents proving the fulfillment of the Good Agricultural and Collection Practices (GACP) requirements by that domestic establishment.

3. Documents attesting the origin of herbal ingredients acquired by a trading facility from domestic individuals cultivating, harvesting or naturally extracting herbal ingredients include: The commitment to sites where herbal ingredients are cultivated and harvested according to the Form No. 06 in the Appendix I enclosed herewith.

4. The document attesting the origin of herbal ingredients in the list of herbal ingredients to be registered is the Certificate of free sale.

5. Documents attesting the origin of traditional drugs include:

- Documents proving the origins of ingredients of traditional drugs;

- Certificate of free sale.

Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam takes effect from June 30, 2018.

- Thanh Lam -

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